Defining Exercise Hemodynamics and Function After Transcatheter Aortic Valve Replacement (DEFINE-TAVR) Study.

Aortic Valve Stenosis Clinical Trial

— DEFINE-TAVR  

Official title:

DEFINE-TAVR (Defining Exercise Hemodynamics and Function After Transcatheter Aortic Valve Replacement) Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05567809
• Other study ID #: 2000033211
• Secondary ID: YSI-002
• Status: Recruiting
• Start date: October 25, 2022
• Est. completion date: October 2024

Study information

• Verified date: June 2023
• Source: Yale University
• Contact: Yousif Ahmad, MD
• Phone: 2037857990
• Email: yousif.ahmad[@]yale.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The purpose of this study is to help understand how the replacement valve functions over time, both at rest and during exercise.

Description:

The objective of this single-center registry is to evaluate prosthetic valve hemodynamics and function over time in patients undergoing clinically indicated transcatheter aortic valve replacement (TAVR) for symptomatic severe aortic stenosis. Specific goals include:

• Describe valve hemodynamics at rest (baseline, post-procedure, 30 days, 1 year) and with exercise (at 30 days and 1 year) after TAVR implantation to define valve function and hemodynamics over time.

• Compare valve hemodynamics and function at rest and exercise between self-expanding and balloon expandable valves.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2024
• Est. primary completion date: June 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or non-pregnant female =18 years of age

• Clinically indicated for TAVR

• Aortic annular size measures 21-25 mm diameter based on pre-procedure Computed Tomography Angiography (CTA)

• Able to exercise and, in the judgment of the investigator, is likely to be physically able to comply with the protocol requirements regarding exercise echocardiography

• Willing to comply with protocol-specified follow-up evaluations

• The participant or legally authorized representative, has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) or Ethics Committee (EC)

Exclusion Criteria:

• Previously implanted prosthetic aortic valve (i.e., planned valve-in-valve TAVR)

• Known mental or physical illness or known history of substance abuse that may cause non-compliance with the protocol, confound the data interpretation, or is associated with a life expectancy of less than one year

• Left ventricular ejection fraction (LVEF) <35%

• Presenting with cardiogenic shock at the time of the index procedure

• Planned to undergo any cardiac surgical procedure in the following 12 months

• The index procedure results in an unsuccessful TAVR, defined as procedural major adverse events (death, disabling stroke, or life-threatening or disabling bleeding), need for a second prosthesis implant, or conversion to emergent surgery

Related Conditions & MeSH terms

• Aortic Valve Stenosis

Locations

Country	Name	City	State
United States	Yale New Haven Hospital	New Haven	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
Yale University	Anteris Technologies Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TransAortic Valve Gradient during exercise at 30 days post-TAVR	TransAortic Valve Gradient (mmHg) during exercise at 30 days post procedure, as assessed by the Echocardiographic Core Laboratory and summarized as peak and mean.	30 days post-TAVR
Secondary	Change in valve cusp thickness at rest	Change in valve cusp thickness (mm) at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in valve mobility at rest	Change in valve mobility at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in paravalvular leak at rest	Change in paravalvular leak at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in coefficient of contraction Effective Orifice Area (EOA)/Geometric Orifice Area (GOA) at rest	Change in coefficient of contraction EOA/GOA at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in Dimensionless Velocity Index (DVI) at rest	Change in DVI at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in energy loss coefficient at rest	Change in energy loss coefficient at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in EOA at rest	Change in EOA (cm2) at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in aortic valve gradient (peak and mean) at rest	Change in aortic valve gradient (mmHg) (peak and mean) at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in aortic valve velocity (peak and mean) at rest	Change in aortic valve velocity (m/s) (peak and mean) at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in Left Ventricle (LV) remodeling at rest	Change in LV remodeling at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in leaflet thickening at rest	Change in leaflet thickening at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in coaptation length at rest	Change in coaptation length (mm) at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in LV thickness at rest	Change in LV thickness (cm) at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in LV Global Longitudinal Strain at rest	Change in LV Global Longitudinal Strain (%) at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in Right Ventricular (RV) systolic velocity at rest	Change in RV systolic velocity (cm/s) at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in RV systolic pressure (RVSP) at rest	Change in RVSP (mmHg) at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in Tricuspid Annular Plane Systolic Excursion (TAPSE) at rest	Change in TAPSE (mm) at rest assessed using echocardiogram reported as absolute values and as changes.	baseline, during hospitalization approximatively 3 days, 30 days, and 12 months post-TAVR
Secondary	Change in aortic valve gradient (peak and mean) with exercise	Change in gradient (mmHg) (peak and mean) with exercise assessed using echocardiogram reported as absolute values and as changes.	30 days, and 12 months post-TAVR
Secondary	Change in aortic valve velocity (peak and mean) with exercise	Change in aortic valve velocity (m/s) (peak and mean) with exercise assessed using echocardiogram reported as absolute values and as changes.	30 days and 12 months post-TAVR
Secondary	Change in DVI with exercise	Change in DVI with exercise assessed using echocardiogram reported as absolute values and as changes.	30 days and 12 months post-TAVR
Secondary	Change in EOA with exercise	Change in EOA (cm2) with exercise assessed using echocardiogram reported as absolute values and as changes.	30 days and 12 months post-TAVR
Secondary	Change in RVSP with exercise	Change in RVSP (mmHg) with exercise assessed using echocardiogram reported as absolute values and as changes.	30 days and 12 months post-TAVR
Secondary	Change in exercise duration	Change in exercise duration (min) reported as absolute values and as changes.	30 days and 12 months post-TAVR
Secondary	Change in LV Global Longitudinal Strain with exercise	Change in LV Global Longitudinal Strain (%) with exercise assessed using echocardiogram reported as absolute values and as changes.	30 days and 12 months post-TAVR
Secondary	TAVR Device Success (Valve Academic Research Consortium [VARC]-defined)	TAVR Device Success evaluated post-procedure/pre-discharge during hospitalization approximatively 3 days, defined as: absence of procedural mortality AND correct positioning of a single prosthetic heart valve into the proper anatomical location AND intended performance of the prosthetic heart valve (defined as no prosthesis-patient mismatch [VARC-defined] and mean aortic valve gradient <20 mm Hg or peak velocity <3 m/s, AND no moderate or severe prosthetic valve regurgitation [VARC-defined] [site and Core Laboratory-reported].	during hospitalization approximatively 3 days
Secondary	Composite Safety Endpoints (VARC-3 defined)	Composite safety endpoint reported as a proportion of participants who died or experienced neurological events or life-threatening bleeding or acute kidney injury or coronary artery obstruction requiring intervention or major vascular complications or valve-related dysfunction requiring repeat procedure evaluated at 30 days and 12 months.	30 days and 12 months post-TAVR